Safety and Preliminary Immunogenicity Study of Inactivated Vaccine for Prevention of Rotavirus Infection

This is an interventional prevention trial for Rotavirus Infection Read More

Inclusion Criteria:

1. 2 months old to 49 years old, healthy resident, excluding the following:

   • Congenital malformations, developmental disorders, genetic defects, severe malnutrition and other conditions；
   • Have Congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus Erythematosus (SLE) , juvenile Rheumatoid Arthritis, or other autoimmune diseases；
   • History of Cerebral Palsy, seizures, mental illness.
2. I and/or my guardian voluntarily participate and sign an informed consent form, and can follow the requirements of the clinical trial protocol;
3. Have never received oral rotavirus live attenuated vaccine.

Exclusion Criteria:

• First dose exclusion criteria:

  1. Armpit temperature >37.0℃ before vaccination；
  2. Subjects with history of intussusception or suffering from intussusception；
  3. Subjects with history of convulsions and convulsions; history of epilepsy, mental illness and their family history；
  4. Subjects with history of allergy to vaccination；
  5. Acute attacks of various acute diseases (fever) or chronic diseases within 3 days before receiving the study vaccine；
  6. Subjects receiving immune enhancement or immunosuppressive therapy within 3 months (continuous oral or infusion for more than 14 days)；
  7. Subjects vaccinated with live attenuated vaccine within 14 days and other vaccines within 7 days before vaccination；
  8. Subjects with history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease);
  9. Subjects with primary and secondary immunocompromised (history of thyroid, pancreas, liver, spleen resection, or need for treatment for thyroid disease in the past 12 months)；
  10. Subjects with abnormal blood biochemistry, blood routine, and urine routine related indicators that have clinical significance* before vaccination；
  11. Subjects who are currently or plan to participate in other clinical studies;

  12. According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

      Note*: The criterion of no clinical significance is "the laboratory test value between the upper limit (ULN) or lower limit (LLN) of the reference value range and the grade 1 adverse event" as judged by the doctor to have no clinical significance.

• In addition to the general exclusion criteria, specific subjects should also follow the following exclusion criteria.

（1）18-49-year-old women who have plans to become pregnant within the past 2 months or are pregnant or are breastfeeding； （2）Positive pregnancy test of female subjects of childbearing age； （3）18-49-year-old adults with hypertension that cannot be controlled by drugs (on site measurement: systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg)； （4）24-month-old infant subjects with a history of dystocia, suffocation rescue, neurological damage； （5）24-month-old baby subjects are born prematurely (delivered after the 37th week of pregnancy), low weight (birth weight for girls <2300g, boys <2500g).

-Exclusion criteria for follow-up needle:

1. Subjects with serious adverse reaction after the previous vaccination;
2. For the subjects who are newly discovered or newly appeared after the first vaccination that do not meet the selection criteria or meet the first exclusion criteria, the investigator will determine whether the subjects continue to participate the clinical trial;
3. Subjects vaccinated with other rotavirus vaccines other than the research vaccine during the study period;
4. Other exclusion reasons considered by the researcher.